Bill S.728

SENATE DOCKET, NO. 113 FILED ON: 1/9/2019

SENATE . . . . . . . . . . . . . . No. 728

By Mr. Tran, a petition (accompanied by bill, Senate, No. 728) of Dean A. Tran for legislation to provide affordable access to generic medicines. Health Care Financing.

The Commonwealth of Massachusetts

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In the One Hundred and Ninety-First General Court
(2019-2020)

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An Act providing affordable access to generic medicines.

Be it enacted by the Senate and House of Representatives in General Court assembled, and by the authority of the same, as follows:

SECTION 1. Section 1 of chapter 23I of the general laws, as appearing in the 2016 Official Edition, is hereby amended by inserting after subsection (10) the following subsection:-

(11) While recognizing that support of the discovery and launch of new therapies is necessary, it is also declared that increasing access to established therapies including generic medicines by addressing shortages, quality issues, and/or affordability of generic medicines is critical to improve the quality and delivery of health care for the people of the commonwealth as well as supports economic development and job growth not just in the life sciences field but throughout all sectors of the economy; and will reduce financial burden on people, businesses, and the commonwealth.

SECTION 2. Section 2 of said chapter 23I, as so appearing, is hereby amended by inserting at the end thereof the following definition:-

"Independent Nonprofit Manufacturing Company”, a nonprofit manufacturing organization that holds tax-exempt status granted under section 501(c)(3) of the Internal Revenue Code and shall be organized and operated primarily to manufacture, virtually or directly, FDA approved medicines, including generics, to increase access by addressing shortages, quality issues, and/or affordability of medicines.

SECTION 3. Subsection (a) of section 5 of said chapter 23I, as so appearing, is hereby amended by inserting after the word “companies”, in line 7, the following:- including independent non-profit manufacturing companies.

SECTION 4. Subsection (b) of said section 5, as so appearing, is hereby amended by inserting after the word “generate”, in line 16, the following:- or for an independent nonprofit manufacturing company healthcare cost savings for the state,

SECTION 5. Subsection (b) of said section 5, as so appearing, is hereby further amended by inserting after the word “revenue”, in line 19, the following:- Or savings,

SECTION 6. Subsection (b) of said section 5, as so appearing, is hereby further amended by inserting after the word “revenue”, in line 20, the following:- Or savings,

SECTION 7. Subsection (b) of said section 5, as so appearing, is hereby further amended by inserting after the word “received”, in line 20, the following:-

Or realized,

SECTION 8. Subsection (f) of said section 5, as so appearing, is hereby amended by inserting after the word “revenue”, in line 154, the following:- or realized savings,

SECTION 9. Subsection (c) of section 6 of said chapter 23I, as so appearing, is hereby amended by striking paragraph (2) in its entirety and replacing it with the following paragraph: -

(2) to make targeted investments, including research funding, proof of concept funding, funding for the manufacture of generic medicines by an independent non-profit manufacturing company through tax-exempt bonds and funding for the development of devices, drugs or therapeutics and to promote manufacturing activities for new or existing advanced technologies and life sciences research;

SECTION 10. Paragraph (3) of subsection (c) of said section 6, as so appearing, is hereby amended by inserting after the word “development”, in line 61, the following:- , increasing access to generic medicines through a non-profit model

SECTION 11. Subsection (d) of said section 6, as so appearing, is hereby amended by inserting after paragraph (7) the following paragraph:-

(8) increase access to generic medicines experiencing shortages, quality issues, and/or affordability issues.

SECTION 12. Paragraph (3) of subsection (e) of said section 6, as so appearing, is hereby amended by inserting after clause (vii) the following clause: -

(viii) or when dealing with an independent nonprofit manufacturing company that is addressing generic medicine access issues that the cost savings that can be realized by

the commonwealth, businesses, and individuals, and / or improvement in healthcare outcomes will be used in place of clauses (iii), (iv), (v), and (vii).

SECTION 13. Paragraph 5 of subsection (e) of said section 6, as so appearing, is hereby amended by inserting after the word “party”, in line 141, the following:- , except when dealing with an independent nonprofit manufacturing company that is addressing generic medicine access issues where this requirement is waived.

SECTION 14. Said paragraph 5, as so appearing, is hereby further amended by inserting after the word “opportunities”, in line 146, the following:- , increase access to generic medicines through a non-profit model

SECTION 15. Clause (v) of paragraph (3) of subsection (c) of section 7 of said chapter 23I, as so appearing, is hereby amended by inserting after the word “enterprise”, in line 60, the following language:- , except when dealing with an independent non-profit manufacturing company that is addressing generic medicine access issues the substantial financial commitment is waived.

SECTION 16. Paragraph 4 of subsection (c) of said section 7, as so appearing, is hereby amended by inserting after the word “opportunities”, in line 78, the following:- , increase access to generic medicines through a nonprofit model,

SECTION 17. Chapter 23I of the general laws is hereby amended by inserting after section 18, the following new section: -

Section 19. The center shall establish a grant program to address access to generic pharmaceuticals. Issues regarding access shall include drug shortages, discontinuations, quality, and/or affordability. To qualify for a grant, an organization must be an independent nonprofit manufacturing company as defined in section 2. The grant funding may be used for startup costs associated with forming an independent nonprofit manufacturing company. To further qualify, an independent nonprofit manufacturing company must abide by all existing state and federal pharmaceutical laws. The center may also create a program to address access to naloxone by those suffering from opioid addiction. This program shall be made available to qualifying independent nonprofit manufacturing companies, but shall not be used to subsidize the purchasing of naloxone. Any qualifying independent nonprofit manufacturing company shall be required to provide to the center all information requested in reference to operating expenses.

Name:	District/Address:
Dean A. Tran	Worcester and Middlesex